Legislative Activity

CR Wrangling

The House approved H. J. Res. 59 last week, a Continuing Resolution (CR) to fund the government through December 15 at sequester funding levels. As expected, the resolution includes a provision that would defund the Affordable Care Act (ACA). The Senate will take up the CR this week, and is expected to reject the defunding provision and send a bill back to the House with potentially higher funding levels, setting up a showdown that will likely run up to the end of the fiscal year. House Republicans have not yet signaled next steps to bring the CR to resolution if and when the Senate returns a bill without ACA defunding language, so the threat of government shutdown remains a prospect.

This Week’s Hearings:

  • Tuesday, September 24: The Senate Committee on Health, Education, Labor and Pensions will hold a hearing titled “U.S. Efforts to Reduce Healthcare-Associated Infections.”
  • Thursday, September 26: The House Committee on the Budget will hold a hearing titled “The Congressional Budget Office’s Long-Term Budget Outlook.”
  • Thursday, September 26: The Senate Committee on Health, Education, Labor and Pensions Subcommittee on Children and Families will hold a hearing titled “Newborn Screening Saves Lives: The Past, Present, and Future of the Newborn Screening System.”

Regulatory Activity

CMS Guidance

The Centers for Medicare & Medicaid Services (CMS) released an interim final rule with comment period on obtaining final Medicare secondary payer conditional payment amounts via web portal. According to the notice, the rule “specifies the process and timeline for expanding CMS’ existing Medicare Secondary Payer (MSP) Web portal to conform to section 201 of the Medicare IVIG and Strengthening Medicare and Repaying Taxpayers Act of 2012 (the SMART Act). The interim final rule specifies a timeline for developing a multifactor authentication solution to securely permit authorized users other than the beneficiary to access CMS’ MSP conditional payment amounts and claims detail information via the MSP Web portal. It also requires that we add functionality to the existing MSP Web portal that permits users to: notify us that the specified case is approaching settlement; obtain time and date stamped final conditional payment summary forms and amounts before reaching settlement; and ensure that relatedness disputes and any other discrepancies are addressed within 11 business days of receipt of dispute documentation.” Comments are due on November 19.

CMS also released a proposed rule that, according to the notice, “would establish methodology and payment rates for a prospective payment system (PPS) for federally qualified health center (FQHC) services under Medicare Part B beginning on October 1, 2014, in compliance with the statutory requirement of the Affordable Care Act. This proposed rule would also establish a policy which would allow rural health clinics (RHCs) to contract with nonphysician practitioners when statutory requirements for employment of nurse practitioners and physician assistants are met, and make other technical and conforming changes to the RHC and FQHC regulations.” Comments are due November 18.

FDA Guidance

The Food and Drug Administration (FDA) released the Unique Device Identification System Final Rule. According to the notice, “[t]his rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA’s Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.” This rule is effective on December 23.